FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756256563
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
D6904
Catalog number
D6904
Device description
ST. Stainless Steel Handle
Published
2021-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDXSCALPEL, ONE-PIECE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756256569PackageGS110In Commercial Distribution
50749756256563PackageGS140In Commercial Distribution
00749756256568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975625656930749756256569
5074975625656350749756256563
00749756256568007497562565687497562565680749756256568

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850069257030LumohsNANO SURGICAL, INCGDX2026-02-20
36945630141820STERiLANCESterilance Medical (Suzhou) Inc.GDX2026-02-05
00850057092998HexaHexa DentalGDX2026-01-21
36945630137588index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137595index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137601index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137618index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630139063index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630139070index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
00194613018825MSI Precision Specialty InstrumentsMed Saver, Inc.GDX2025-08-01
00642356001425Mastel Precision Surgical Instruments, Inc.Mastel Precision Surgical Instruments, Inc.GDX2025-07-08
00642356001432Mastel Precision Surgical Instruments, Inc.Mastel Precision Surgical Instruments, Inc.GDX2025-07-08
00642356001449Mastel Precision Surgical Instruments, Inc.Mastel Precision Surgical Instruments, Inc.GDX2025-07-08
00810111224482Scalpel Treace Medical Concepts, Inc.GDX2025-05-06
00810111224543Scalpel Treace Medical Concepts, Inc.GDX2025-03-25
36945630135805BardSterilance Medical (Suzhou) Inc.GDX2025-03-21
06945630114083BardSterilance Medical (Suzhou) Inc.GDX2025-02-28
05063043035045Swann Morton Ltd.SWANN-MORTON LIMITEDGDX2024-12-27
05063043036042Swann Morton Ltd.SWANN-MORTON LIMITEDGDX2024-12-27
20197344025197MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
20197344025203MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
20197344025210MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
28902895129216KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129223KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129230KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129247KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129285KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129377KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895148095KIATOADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895148101KIATOADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09